← Back to all trials
Completed
NCT05572333
Clinical Trial to Investigate the Safety and Tolerability of EP395 in Patients With COPD
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Sex: All
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 61
Sponsor: EpiEndo Pharmaceuticals
Location: IKF Pneumologie GmbH & Co. KG Frankfurt
Summary
The aim of this clinical trial is to investigate the safety and tolerability of oral, once-daily EP395 administration in COPD patients for 12 weeks.
Eligibility Criteria
Inclusion Criteria:
1. Willing and able to understand the information on the nature, the scope, and the relevance of the study, and to provide voluntary, written informed consent to participate in the study before any study-related procedures
2. Men and women, aged ≥45 years
3. Women of childbearing potential must:
1. have a negative pregnancy test (blood) at Screening and (urine) Day 1
2. agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, during study participation and until 90 days after the last investigational product (IP) intake.
3. agree to abstain from breast feeding during the study participation and for 90 days after the last IP intake.
4. Men must agree to use a condom during sexual intercourse with women of childbearing potential during treatment and for 90 days after the last IP intake and should not donate sperm during this time
5. Diagnosed with COPD for at least 2 years with FEV1/forced vital capacity (FVC) ratio \
Source: ClinicalTrials.gov (NCT05572333). StuddyBuddy aggregates publicly available trial information.